Regulatory Watch - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Regulatory Watch

Industry Seeks Clearer Standards for Track and Trace

July 2, 2014

Pharmaceutical Technology

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Regulating the Environmental Impact of Pharmaceuticals

June 2, 2014

Pharmaceutical Technology

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

Global Expansion Shapes Drug Oversight

June 2, 2014

Pharmaceutical Technology

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Demand for New Vaccines Spurs Innovation

May 2, 2014

Pharmaceutical Technology

New formulations and expanded vaccine production are encouraged.

Quality by Design—Bridging the Gap between Concept and Implementation

April 2, 2014

Pharmaceutical Technology

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

April 2, 2014

Pharmaceutical Technology

New identifiers and tracking requirements aim to block illegitimate products.

European Union Packaging Safety Features Come into Effect

March 2, 2014

Pharmaceutical Technology

Manufacturers are taking measures to comply with new package safety rules.

Manufacturers Struggle with Breakthrough Drug Development

March 2, 2014

Pharmaceutical Technology

Accelerated testing and production create challenges in documenting product quality.

FDA Focuses on Drug Appearance and Attributes

February 2, 2014

Pharmaceutical Technology

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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